Category Archives: C. diff. prevention

The use of antibiotics among Americans with commercial health insurance has decreased during the past several years, according to a new analysis that nevertheless
shows lingering variations for different ages and in different parts of the country.

The study released provides the latest evidence of how doctors and patients have begun to heed warnings that excessive antibiotic use breeds dangerous drug resistance and “superbug” bacteria.

The analysis is based on 173 million insurance claims from people under age 65 with Blue Cross Blue Shield coverage
who filled prescriptions
between 2010 and 2016.

It is a sequel of sorts to research by the federal Centers for Disease Control and Prevention, which found a smaller decline and comparable age and geographic variations.

The CDC reported a 5 percent decrease overall between 2011 and 2014 in antibiotic prescriptions written in outpatient settings such as doctors’ offices, clinics and hospital emergency rooms.

The study by the Blue Cross Blue Shield Association found that 9 percent fewer antibiotics prescribed in outpatient settings were filled in 2016, compared with 2010.

In a recent study that assessed the level of fungal contamination in bedding, researchers found that a test sample of feather and synthetic pillows that were 1 1/2 to 20 years old contained as many as 16 species of fungus each.

And it’s not just your own microbial life you’re sleeping with. In addition to the fungi and bacteria that come from your sweat, sputum, skin cells, and vaginal and anal excretions, you also share your bed with foreign microbes.

These include animal dander, pollen, soil, lint, dust mite debris and feces, and finishing agents from whatever your sheets are made from, to name a few.

Tierno says all that gunk becomes “significant” in as little as a week. And unclean bedding still exposes you to materials that can trigger the sniffing and sneezing, since the microbes are so close to your mouth and nose that you’re almost forced to breathe them in.

“Even if you don’t have allergies per se, you can have an allergic response,” Tierno said.

Another reason your sheets get dirty quickly has little to do with your behavior or sweat patterns — the issue is simply gravity.

“Just like Rome over time was buried with the debris that falls from gravity, gravity is what brings all that material into your mattress,” Tierno said.

One to two weeks of this buildup is enough to leave anyone with a scratchy throat — especially those with significant allergies or asthma. (One in six Americans has allergies.)

“Consider that analogous to your bedding. If you saw what was there — but of course you don’t see it — after a while you have to say to yourself, ‘Do I want to sleep in that?’

So what does Dr. Tierno suggest?

To stem the invisible tide, he said, sheets should be washed once a week — >> More Often when bed linens are visibly soiled and an infection is being treated <<

Proper ways to handle soiled linens:

There is now a common understanding that linens, once in use, are usually contaminated and could be harboring microorganisms such as MRSA and VRE.

Further, the Centers for Disease Control and Prevention (CDC) cautions that healthcare professionals should “handle contaminated textiles and fabrics with a minimum agitation to avoid contamination of air, surfaces, and persons.” Even one of the leading nursing textbooks, Fundamentals of Nursing, states, “Soiled linen is never shaken in the air because shaking can disseminate secretions and excretions and the micro organisms they contain.” This text also states, “…linens that have been soiled with excretions and secretions harbor microorganisms … can be transmitted to others.”

According to Fundamentals of Nursing, when handling linens in any acute care and healthcare facility:

1. You should always wash your hands after handling a patient’s bed linens.

2. You should hold soiled linen away from your uniform.

3. Soiled linen is never shaken in the air because shaking can disseminate the micro-organisms they contain.

4. Linen from one patient’s bed is never (even momentarily) placed on another patient’s bed.

5. Soiled linens should be placed directly into a portable linen hamper or tucked into a pillowcase and the end of the bed before it is gathered up for disposal in the linen hamper or linen chute.

To read this article in its entirety – please click on the following link:

CDI is not only observed in hospitalized patients and patients with antibiotic exposure but also in populations previously thought to be at low risk, such as healthy young adults and children. Community-associated CDI has also emerged as an important cause of diarrheal illness.4,5 The spectrum of CDI ranges from asymptomatic carriage and mild diarrhea to life-threatening pseudomembranous colitis, toxic megacolon, and fulminant colitis potentially requiring urgent colectomy.4-6 Furthermore, long-term resolution of symptoms is difficult to achieve in a large percentage of patients with CDI; approximately 20% of patients with CDI experience recurrent infection after responding to initial therapy.2

Although the pathophysiology of CDI is complex and multifactorial, toxin B (TcdB), a cytotoxin, is now thought to be the primary mediator of symptomatic infection. Toxin A (TcdA) and binary toxin (in particular strains such as epidemic strain BI/NAP1/027) are also likely to do so, but the extent to which they contribute to disease is unclear.5 A mature and varied intestinal microbiome confers resistance to colonization by C difficile, protecting against CDI.6 Thus, exposure to C difficile spores alone is rarely sufficient to cause CDI, while perturbation of the microbiome following antibiotic exposure permits C difficile spores to colonize, germinate, and release toxins that induce CDI symptoms.

Bezlotoxumab, a monoclonal antibody against TcdB recently approved by the US Food and Drug Administration (FDA), reduces the rate of CDI recurrence in adults.8 However, the protective effect of this passive immunization strategy is short-lived.

Vaccines appear to be a promising intervention that provides long-term protection against CDI episodes, and several are in various stages of development.6 There are 3 candidate vaccines currently undergoing phase 2 and 3 clinical evaluation for CDI prevention.6

The Sanofi Pasteur toxoid vaccine uses formalin-inactivated full-length TcdA and TcdB administered by intramuscular injection at days 0, 7, and 30. In phase 2 trials, the vaccine was safely administered to adults older than 50, and seroconversion to TcdA and TcdB was 97% and 92%, respectively.9 The high-dose adjuvanted vaccine, which is currently being evaluated in a phase 3 clinical trial, has demonstrated elevated circulating titers for up to 3 years after the last dose of the primary series given at 0, 7, and 30 days.10

Pfizer is currently evaluating a genetically modified and chemically treated recombinant full-length TcdA and TcdB vaccine in a phase 2 trial. In a phase 1 trial with 3 different dosages given as a 3-dose schedule in adults 50 to 85 years old, satisfactory immunogenicity and safety were demonstrated for both the aluminum hydroxide-adjuvanted and non-adjuvanted vaccine.11 Best responses were observed with the non-adjuvanted formulation, and there were no differences in responses in 50- to 64 year-old and 65- to 80 year-old subjects.

Valneva, an Austrian pharmaceutical company, is developing VLA84, a genetic fusion of the truncated cell-binding domains of TcdA and TcdB that is purported to be less complex to produce and purify compared with the toxoid vaccines. In a phase 1 trial, VLA84 was shown to be highly immunogenic in adults and the elderly without serious adverse effects.12 A phase 2 clinical trial has been completed, but data are not yet available.

All 3 of these parenteral candidate vaccines are moving forward in development and appear promising for the prevention of symptomatic CDI. An oral mucosal vaccine using a genetically engineered Bacillus subtilis vector is also in development.13 Because host immune response against non-toxin antigens may additionally protect against colonization and subsequent transmission, an alternative possibility of developing vaccines against surface proteins that prevent C difficile mucosal adherence and colonization is attractive. To this end, a number of surface-associated antigens including flagellar proteins, S-layer proteins, proteases, and complex polysaccharides have been studied in animal models as possible vaccine candidates.14

Larry K. Kociolek, MD, is the associate medical director of Infection Prevention and Control at The Ann & Robert H. Lurie Children’s Hospital of Chicago and assistant professor of Pediatrics at the Northwestern University Feinberg School of Medicine in Illinois.

Stanford T. Shulman, MD, is the medical director of Infection Prevention and Control at The Ann & Robert H. Lurie Children’s Hospital of Chicago and Virginia H. Rogers Professor of Pediatric Infectious Disease​ at the Northwestern University Feinberg School of Medicine​ in Illinois.

The C Diff Foundation’s organization is comprised of 100% volunteering members who are dedicated to our mission and adhere to the Foundation’s Code of Ethics

which prohibits the endorsement and promotion of products, services, medications, or clinical studies in progress.

All website entries, public presentations, and workshops are to raise C. diff. infection awareness in all areas of the C Diff Foundation’s mission statement, including infection prevention, sepsis, healthcare-associated infections, antimicrobial resistance, antibiotic stewardship and provide education on all the above.”

C. difficile is an Increasing Worldwide Concern Associated with Approximately 29,000 Annual Deaths in the U.S. Alone
On Thursday, January 26, 2017 Pfizer Inc. announced that the Phase 2 study
evaluating the Company’s Clostridium difficile (C. difficile) vaccine
candidate, PF-06425090, provided positive data, based on a pre-planned interim analysis.

The randomized Phase 2 study (NCT02561195) examined the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer’s vaccine candidate is designed to help prevent C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis,1 by inducing a functional antibody response capable of neutralizing the two main disease-causing toxins produced byC. difficile (toxins A and B).2

“Despite improved infection control measures, C. difficile disease continues to rise, further augmenting an already urgent public health threat with particular negative impact on older adults,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. “We are very encouraged by these interim immunogenicity and safety results demonstrating robust increases in vaccine-elicited neutralizing antibodies to both toxins, that we believe could provide protection against C. difficile disease.”

Based on findings from the pre-planned interim analysis, Pfizer’s C. difficile vaccine candidate will progress into Phase 3 in the first half of 2017.

Pfizer’s C. difficile vaccine candidate was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in August 2014. The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.3 About the Phase 2 Study The Phase 2 study (NCT02561195) was a randomized, placebo-controlled, observer-blinded study of more than 850 healthy adults 65-85 years of age, evaluating the safety, tolerability, and immunogenicity of two dose levels (100 µg and 200 µg) of Pfizer’s C. difficile vaccine candidate on two different three-dose vaccination schedules (Days 1/8/30 and Months 0/1/6). More information about the PF-06425090 Phase 2 study can be found at www.clinicaltrials.gov (link is external).

About Clostridium difficile

Clostridium difficile (C. difficile) is a spore-forming pathogen that typically causes symptoms in individuals with altered gut microbial flora, releasing toxins that can result in a range of disease manifestations from asymptomatic colonization to diarrhea, pseudomembranous colitis, toxic megacolon, intestinal perforation, or, in the most severe cases, death.4,5 C. difficile, classified by the U.S. Centers for Disease Control and Prevention (CDC) as an urgent public health threat in 2013,6 is the most common cause of antibiotic-associated diarrhea in the healthcare setting and an increasing concern worldwide.7 Responsible for approximately 453,000 U.S. cases (associated with 29,000 deaths) in 2011,8 CDI disproportionately affects older adults, with nearly two-thirds of cases in patients over the age of 65.9 Current treatment options may offer temporary therapeutic improvements, but will not provide long-term protection.10 Up to 25% of patients treated for a first episode of CDI experience a first recurrence of infection, and up to 65% of those patients who experience a first recurrence will experience multiple recurrences.1,11

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of January 26, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about a vaccine candidate, PF-06425090, including its potential benefits and the expected timing of commencement of a Phase 3 study, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with interim data; whether and when any biologics license applications may be filed for PF-06425090; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of PF-06425090 and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov (link is external) and www.pfizer.com.

The rates of initial clinical cure were 80% with bezlotoxumab alone, 73% with actoxumab plus bezlotoxumab, and 80% with placebo; the rates of sustained cure (initial clinical cure without recurrent infection in 12 weeks) were 64%, 58%, and 54%, respectively.

The rates of adverse events were similar among these groups; the most common events were diarrhea and nausea.

Conclusions Among participants receiving antibiotic treatment for primary or recurrentC. difficile infection, bezlotoxumab was associated with a substantially lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo.

The addition of actoxumab did not improve efficacy. (Funded by Merck; MODIFY I and MODIFY II ClinicalTrials.gov numbers, NCT01241552 and NCT01513239 .).Also Resource:

Synthetic Biologics, Inc. a late-stage clinical company developing therapeutics
that preserve the microbiome to protect and restore the health of patients, today
announced positive topline data from its Phase 2b clinical trial for SYN-004 (ribaxamase),
the Company’s first-in-class oral enzyme designed to protect the gut microbiome
from disruption caused by certain intravenous (IV) beta-lactam antibiotics.

Synthetic Biologics is also in the process of analyzing data from several exploratory endpoints that were designed to evaluate ribaxamase’s ability to protect the gut microbiome from colonization by opportunistic bacteria such as C. difficile and other antibiotic-resistant pathogens. Preliminary analysis of the data demonstrated a significant reduction in new colonization by vancomycin-resistant enterococci (VRE) for patients receiving ribaxamase compared to placebo (p-value=0.0002). With agreement from the FDA, the study included a secondary endpoint to assess ribaxamase’s capacity to decrease the incidence of antibiotic-associated diarrhea from all causes. Preliminary analysis of the data suggested a trend towards such a reduction (p-value=0.13), which was due, for the most part, to the reduction of CDI.

These data are consistent with ribaxamase’s mechanism of action designed to protect and preserve the natural balance of the gut microbiome from the unintended effects of IV antibiotic use. The Company expects to share additional results from these exploratory endpoints as they become available later this year, including results focused on ribaxamase’s ability to prevent the emergence of antimicrobial resistance in the gut microbiome.

“These trial results provide a compelling demonstration of the potential of ribaxamase to help address the serious health impacts associated with CDI and infections from other opportunistic bacteria resulting from dysbiosis of the gut microbiome,” said Joseph Sliman, MD, SVP, Clinical and Regulatory Affairs. “More than 453,0001 patients are diagnosed with CDI annually in the U.S., resulting in approximately 29,0001 deaths as well as significant and sometimes prolonged illness. Ribaxamase has the potential to shorten hospital stays, diminish morbidity and mortality and reduce the emergence of antibiotic-resistant organisms in the gut microbiome by protecting patients from primary C. difficile infection resulting from IV antibiotic use.”

In addition to causing significant suffering and mortality, CDI adds an estimated economic burden of nearly $1.5 billion1 to the healthcare system each year, which could potentially be reduced with an effective therapeutic.

“The reduction in the relative risk of CDI represents a significant milestone in the clinical development of ribaxamase and we believe provides further validation for our approach to advancing cutting edge microbiome science,” said Jeffrey Riley, President and Chief Executive Officer. “These findings also help further our goals to bring the first ever microbiome-focused therapeutic to patients and to help illuminate the potential of this drug class to address serious diseases and public health concerns. We expect to share additional data from exploratory endpoints in the coming months and look forward to continuing ongoing and productive discussions with both the FDA and CDC on the protocol for Phase 3 pivotal trials for ribaxamase.”

Synthetic Biologics is also continuing to prepare for the initiation of pivotal Phase 2b/3 clinical trials for SYN-010, the Company’s proprietary, modified-release formulation of lovastatin lactone designed to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C).

SYN-004 (ribaxamase) is a first-in-class oral enzyme designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of CDI, AAD and the emergence of antibiotic-resistant organisms. The Phase 2b proof-of-concept clinical trial is intended to evaluate the effectiveness of ribaxamase to prevent the onset of primary C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms in patients hospitalized with a lower respiratory infection and receiving IV ceftriaxone. A total of 412 subjects were randomized in a 1:1 ratio receiving either 150 mg dose strength of SYN-004 (ribaxamase) or placebo orally QID from Day 1 and until 72 hours following their last treatment of IV ceftriaxone. The sample size was determined to provide 80% power to detect the treatment effect with a one-sided alpha of 0.05. P-values were determined based on a 1-sided z-test for the comparison of the treatment difference as pre-specified in the statistical analysis plan. To access the ribaxamase mechanism of action video on Synthetic Biologics’ website, please click here.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients. The Company’s lead candidates poised for Phase 3 development are: (1) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C), and (2) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. The Company is also developing preclinical stage monoclonal antibody therapies for the prevention and treatment of pertussis and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates” and similar expressions and include statements regarding the potential ofribaxamase to help address the serious health impacts associated with CDI and infections from other opportunistic bacteria resulting from dysbiosis of the gut microbiome, the industry data regarding the expected incidence and economic burden of CDI, the potential of ribaxamase to shorten hospital stays, diminish morbidity and mortality and reduce the emergence of antibiotic resistant organisms in the gut microbiome by protecting patients from primary C. difficile infection resulting from IV antibiotic use, the potential to reduce the economic burden to the healthcare system from an effective therapeutic, the suggested trend toward a reduction of incidence of antibiotic-associated diarrhea from all causes, the expected timing of data release of exploratory endpoints of the trial focused on the ability of ribaxamase to prevent the emergence of antibiotic-resistant organisms in the gut microbiome, the continued ongoing discussions with the FDA and CDC, validation for our approach to advancing cutting edge microbiome science, the continued preparation for the initiation of pivotal Phase 2b/3 clinical trials for SYN-010, the potential of the drug class to address serious diseases and public health concerns, the ability of SYN-004 to protect the gut microbiome from the effects of certain commonly used IV beta-lactam antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements.Important factors that could cause actual results to differ materially from current expectations include, among others, Synthetic Biologics’ product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, Synthetic Biologics’ ability to initiate clinical trials and if initiated, to complete them on time and achieve desired results and benefits, Synthetic Biologics’ clinical trials continuing enrollment as expected, Synthetic Biologics’ ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Synthetic Biologics’ ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics’ products by competitors that render Synthetic Biologics’ products obsolete or non-competitive, Synthetic Biologics’ ability to maintain its license agreements, the continued maintenance and growth of Synthetic Biologics’patent estate, Synthetic Biologics becoming and remaining profitable, Synthetic Biologics’ability to establish and maintain collaborations, Synthetic Biologics’ability to obtain or maintain the capital or grants necessary to fund its research and development activities, a loss of any of Synthetic Biologics’key scientists or management personnel,and other factors described in Synthetic Biologics’ Annual Report on Form 10-K for the year ended December 31, 2015 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K.The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

When most people think of hospitals, they imagine a safe, clean environment where patients can comfortably receive treatments in an effort to get healthy. However, in reality, hospitals can pose potential risks to both patients and staff, through the threat of infections caused by pathogens such as MRSA, E. coli and C. difficile (C. diff.).

Remarkably, C. diff contributes to nearly 29,000 deaths every year – almost matching the number of deaths caused by influenza.[i] Despite the prevalence of this organism, prevention and containment pose numerous challenges as the spores can survive for weeks on a large variety of surfaces.

Now available for use in the U.S., the new product delivers on effectiveness, efficiency and value, by providing the following:

Effectiveness

EPA-registered to kill diff spores in four minutes

Effective against Norovirus

Safer than bleach and peracetic acid, featuring an NFPA rating of 0,0,0 with no personal protective equipment required at use dilution

In-use pH of 5.5 to 6.5, which is closer to neutral than bleach or peracetic acid

Efficiency

Dissolves in approximately three minutes with a mild chlorine smell

Tablets are available in two sizes for use in large and small containers

The product can be applied with a cloth, wipe, mop, or coarse trigger sprayer, and will not bind to common wiping media

Value

Costs significantly less than ready-to-use bleach

Yields a three-year shelf life in sealed packets, and seven-day shelf life when diluted and stored in a closed container

“We are excited to provide our customers with an effective solution for the battle against C. diff,” said Adrian Cook, product marketer for chemicals at 3M Commercial Solutions Division. “The reduction and prevention of infections is an important focus for our customers and we look forward to continuing our work in ensuring safe environments.”

In addition to the new product launch, 3M Commercial Solutions Division also announced the expansion of its Flow Control System product line through the introduction of four additional chemical offerings:

Hours & Info

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